Regulation of stem cell research in Bulgaria
Embryonic stem cells can be derived legally from surplus embryos donated following IVF treatment.
Current legal position
Human embryonic stem cell research and the derivation of human embryonic stem cell lines is not directly regulated by Bulgarian legislation, but falls partially within the scope of the Bulgarian Health Act (promulgated SG No. 70/10 August 2004, into force from 1 January 2005). According to the act, surplus embryos donated following IVF treatment can be used for research purposes, subject to the informed consent of the donor(s). The reproductive cloning of people is prohibited, including that for the purposes of donating organs, tissues and cells.
The Law on Transplantation of Organs, Tissues, and Cells (promulgated SG No. 83/19 September 2003, into force 1 January 2004) regulates the use, collection and storage (including biobanks) of all cells, organs and human tissue in Bulgaria.
Ethical and regulatory oversight
Medical research on human subjects is mainly overseen by the Bulgarian Central Ethics Commission (CEC), which is accountable to the Ministry of Health. It gives opinions on ethical issues in relation to clinical trials and medicinal products. There are also Local Ethics Committees (LECs), which are independent bodies at individual hospitals and report to the CEC annually. The remit of the CEC and LECs extends to giving ethical opinions, but not to accepting or rejecting applications. The opinion is given to the institution requesting it: the Minister of Health, the Specialized Committee for Approval of Conducting Clinical Trials, or the Bulgarian Drug Agency. These bodies have the authority to reject the application on ethical grounds.
The ethics committees of individual institutions provide ethical review of research projects seeking funding from the National Science Fund or local funding bodies, and are monitored by the Central Committee on Research Ethics at the Ministry of Education and Sciences. For example, the Ethics Committee on Medical Research of the Medical University (Sofia) provides independent advice on ethical aspects of medical research performed at that university.
The Executive Agency for Transplantation controls and co-ordinates activities related to transplantations carried out at medical institutions.
The Bulgarian Centre for Bioethics is a non-governmental organization that addresses bioethics problems on a national and international level, but does not have a formal status.
Relevant laws, policies and links
- The Health Act (Promulgated in the State Gazette, issue No. 70/10 August 2004, entered into force on 1 January 2005), at http://solicitorbulgaria.com/index.php/bulgarian-health-act-part-2
- Law on the Transplantation of Organs, Tissues and Cells (Promulgated in the State Gazette, issue No. 83/19 September 2003, entered into force on 1 January 2004), at http://bgtransplant.bg/iat/docs/Law%20on%20transplantation.doc (Word download), accessed 10 October 2011. Закон за Трансплантация на Органи, Тъкани и Клетки (обнародван в ДВ, бр. 83 от 19-ти септември 2003г., в сила от 1-ви януари 2004г.), at http://www.mh.government.bg/Articles.aspx?categoryid=2997&lang=bg-BG&pageid=380, accessed 10 October 2011.
- Regulation on the terms and conditions of activity of the central ethics commission under the Council of Ministers in accordance with the Law of Medicinal Products in Human Medicine (adopted 28 September 2007, SG 81/0 October 2007), at: http://lex.bg/en/laws/ldoc/2135566887, accessed 7 November 2011.
- S. Tomova “Research ethics committees in Bulgaria”, in D. Beyleveld, D. Townend and J. Wright (eds.), Research ethics committees, data protection and medical research in European countries (Aldershot: Ashgate, 2005), pp. 27–9.
- Устройствен Правилник на Изпълнителната Агенция по Трансплантация (приет с ПМС No. 34 от 17-ти февруари 2004г., обнародван в ДВ, бр. 15 от 24-ти февруари 2004г.), at http://www.lex.bg/bg/laws/ldoc/2135479831, accessed 6 November 2011.
- Bulgarian Centre for Bioethics, at http://www.bio-ethics.net/en/content/mission, accessed 7 November 2011.
- Order No. 28 of 20 June 2007 on assisted reproduction (Promulgated in the State Gazette, issue No. 55/6 July 2007). Наредба № 28 от 20 юни 2007 Г. за Дейности по Асистирана Репродукция (обнародвана в ДВ, бр. 55 от 6-ти юли 2007г.), at http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=391¤tPage=2&categoryid=4838 accessed 13 August 2012.
- Law on Blood, Blood Donation and Blood Transfusion (Promulgated in the State Gazette, issue No. 102/21 November 2003), at http://www.mlsp.government.bg/BG/integration/euro/chapter13/euro/09.Public%20Health/02.bg%20legislation/law%20on%20blood%20en.pdf, accessed 10 October 2011. Закон за Кръвта, Кръводаряването и Кръвопреливането (обнародван в ДВ, бр. 102 от 21-ви ноември 2003г.), at http://www.lex.bg/bg/laws/ldoc/2135474551, accessed 10 October 2011.
- Ordinance No 22 of the Ministry of Health, dated 3 May 2007, on the Terms and Conditions of the Registration and Reporting of the Activities of Investigation, Extraction, Transplanting, Processing and Reprocessing, Conservation and Labeling of Organs, Tissues and Cells for Preparation of Annual Reports of the Health Institutions (Promulgated in the State Gazette, issue No. 39/15 May 2007). Наредба No. 22 на МЗ от 03 май 2007г. за Условията и Реда за Регистриране и Отчитане на Дейностите по Експертиза, Вземане, Присаждане, Обработка, Преработка, Съхраняване и Етикетиране на Органи, Тъкани иКлетки и за Изготвяне на Ежегодни Отчети от Лечебните Заведения (Обнародвана в ДВ. бр.39 от 15 Май 2007г.) at http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=391&categoryid=314&articleid=444, accessed 10 October 2011.
- Ordinance No 13 of the Ministry of Health, dated 4 April 2007 on the Terms and Conditions for Informing the Bulgarian Citizens on the Activities on Extraction and Transplantation of Organs, Tissues and Cells (Promulgated in the State Gazette, issue No. 34/24 April 2007). Наредба No. 13 на МЗ от 4-ти април 2007г. за Условията и Реда за Информиране на Българските Гражданиза Дейностите по Вземане и Присаждане на Органи, Тъкани и Клетки (Обнародвана в ДВ, бр. 34 от 24-тиАприл 2007г.) at: http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=391&categoryid=314&articleid=455, accessed 10 October 2011.
- Ordinance No 7, of the Ministry of Health, on the Requirements for Qualification and Health Status of the Personnel Carrying out Extraction, Investigation, Processing and Reprocessing, Labeling and Conservation of Tissues and Cells (Promulgated in the State Gazette, issue No. 23/16 March 2007). Наредба No. 7 на МЗ от 5-ти март 2007г. за Изискванията към Квалификацията и Здравословното Състояниена Лицата, Които Извършват Вземане, Експертиза, Обработка, Преработка, Ртикетиране и Съхраняване на Тъкани и Клетки (Обнародвана в ДВ, бр.23 от 16-ти Март 2007г.) at http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=391&categoryid=314&articleid=465, accessed 10 October 2011.